FDA 483 OBSERVATION · #874 OF 1,000 MOST-CITED
Procedures and release criteria
FDA cited this observation 17 times across 16 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
Procedures including release criteria for activities relating to the receipt and distribution of HCT/Ps were not maintained, implemented, reviewed and revised.
Procedures including release criteria for activities relating to the distribution of HCT/Ps were not established and maintained.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not established and documented.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not documented, implemented and followed.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not established.
Procedures including release criteria for activities relating to the receipt of HCT/Ps were not followed.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.